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Intravenous Thrombolysis With rhTNK-tPA for Acute Non-large Vessel Occlusion in Extended Time Window

NCT05752916 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2025-12-02

No results posted yet for this study

Summary

This study is designed to evaluate the efficacy of IV rhTNK-tPA between 4.5 to 24 hours from symptom onset in patients presenting with a non-large vessel occlusion ischemic stroke.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

rhTNK-tPA

Recombinant human TNK tissue-type plasminogen activator. Patients will receive intravenous rhTNK-tPA (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds).

DRUG

Antiplatelet Agents

Aspirin (150-300mg) is offered to patients allocated in the control arm, unless contraindicated. According to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023, 150-300mg aspirin alone is recommended for acute stroke treatment in patients who are otherwise eligible for intravenous thrombolysis or EVT as soon as possible (Class 1 of recommendation, Level A of evidence). The aspirin dose can be changed to 50-300 mg/day after the acute phase. Clopidogrel is indicated as an alternative in case of aspirin intolerance (Class 2 of recommendation, Level C of evidence)

Sponsors & Collaborators

  • CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

    collaborator INDUSTRY

  • Beijing Hospitals Authority

    collaborator UNKNOWN

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Junwei Hao, MD · Xuanwu Hospital, Beijing

  • Qingfeng Ma, MD · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2025-10-28
Completion
2025-10-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05752916 on ClinicalTrials.gov